At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 671 enrolled
Drug / intervention
Trivalent influenza vaccine (TIVc) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II, Randomized, Observer-Blind, Multicenter Study to Evaluate Immunogenicity and Safety of Four Influenza Vaccines in Healthy Pediatric Subjects 6 to < 48 Months of Age.
In Brief
A Phase 2 clinical trial evaluating Trivalent influenza vaccine (TIVc) and Trivalent influenza vaccine-licensed for Influenza. Completed, enrolled 671 participants across 27 sites in 4 countries.
Detailed Summary
To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to \< 48 months of age
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesFinland, Philippines, Thailand, United States
CollaboratorsNovartis Vaccines
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedJan 2014
Primary CompletionJun 2014
Study CompletionDec 2014
TodayJul 2026
First PostedJan 14, 2014
Enrollment StartDec 1, 2013
Primary CompletionJun 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.5 years ago
Interventions
Trivalent influenza vaccine (TIVc)biological
Trivalent influenza vaccine-licensedbiological
Licensed influenza vaccine